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Mirabegron composition

A technology for Mirabegron and sustained-release tablets, which is applied in the field of Mirabegron composition and its preparation, and can solve the problems of exceeding the standard of substances and substandard content uniformity.

Inactive Publication Date: 2017-02-01
DISHA PHARMA GRP +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese patent 201410460602.5 discloses a Mirabegron sustained-release tablet, which solves the problem of related substances exceeding the standard; 201410811156.8 discloses a Mirabegron sustained-release tablet, which provides a sustained-release tablet with a safe matrix
[0006] In the process of preparing sustained-release tablets, the applicant found that the content uniformity was not up to standard, especially for 25mg tablets

Method used

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  • Mirabegron composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1. Mirabegron 25g, hypromellose (K4M) 80g, dibutylhydroxytoluene 0.15g, polyoxyethylene (POLYOX N80) 50g, polyethylene glycol 6000 8g, lactose 18g, hard Magnesium fatty acid 0.8g, powdery silicon dioxide 8g, prepare 1000 tablets according to the preparation method described in the technical scheme.

Embodiment 2

[0025] Example 2, Mirabegron 50g, hypromellose (K4M) 150g, dibutylhydroxytoluene 0.3g, polyoxyethylene (POLYOX N80) 80g, polyethylene glycol 6000 26g, lactose 25g, hard Magnesium fatty acid 1.4g, powdery silicon dioxide 15g, prepare 1000 tablets by the preparation method described in the technical scheme.

Embodiment 3

[0026] Example 3, Mirabegron 25g, hypromellose (K4M) 90g, dibutylhydroxytoluene 0.15g, polyoxyethylene (POLYOX N80) 60g, polyethylene glycol 6000 10g, lactose 18g, hard Magnesium fatty acid 0.8g, powdery silicon dioxide 9g, prepare 1000 tablets according to the preparation method described in the technical scheme.

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Abstract

The invention relates to a Mirabegron composition and a preparing method thereof, and belongs to the technical field of pharmaceuticals. According to the technical scheme, a Mirabegron sustained release tablet is characterized in that every one thousand compositions are prepared from 25 g-50 g of Mirabegron, 80 g-150 g of hydroxypropyl methylcellulose (K4M), 0.15 g-0.3 g of butylated hydroxytoluene, 50 g-80 g of polyoxyethylene (POLYOX N80), 8 g-26 g of polyethylene glycol6000, 18 g-25 g of lactose, 0.8 g-1.4 g of magnesium stearate and 8 g-15 g of powdery silicon dioxide. According to the technical scheme, the Mirabegron sustained release tablet with the even content is obtained, and the safe medicine is provided for clinic.

Description

technical field [0001] The invention relates to a Mirabegron composition and a preparation method thereof, belonging to the technical field of pharmacy. Background technique [0002] Overactive bladder (OAB) is a syndrome characterized by urinary urgency symptoms, often accompanied by frequent urination and nocturia, with or without urge incontinence, which obviously affects the daily life and social activities of patients, and has been Become a major disease that plagues people. In recent years, as my country has entered an aging society, and the growth of diabetes and nervous system damage diseases, the incidence of related diseases secondary to this - overactive bladder has also increased year by year. [0003] It has been reported that the overall prevalence of overactive bladder (OAB) is 6% for people over the age of 18, and can reach 11.3% for people over the age of 50, which has seriously affected people's quality of life. According to the guidelines for the diagnos...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/426A61K47/10A61K47/26A61K47/04A61P13/10A61P13/00
CPCA61K9/2031A61K9/0002A61K9/2009A61K9/2018A61K31/426
Inventor 孙金枝伊凌宇金栋霞
Owner DISHA PHARMA GRP
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